Supplier Quality Engineer III – Electrophysiology Devices

Boston Scientific Gruppe; Arden Hills, Northern (MN, KY); Hybrid; USD 78,000 - 149,000; Full time

Job summary

Boston Scientific is seeking a Supplier Quality Engineer III for Electrophysiology External Operations. You will support SFMD products, onboard suppliers, and lead quality deliverables across global teams. The role emphasizes patient safety, with a hybrid office schedule and travel up to 25%.

The position focuses on ensuring finished device quality, applying quality tools, and maintaining rigorous supplier qualification within the EP portfolio.

Qualifications

• BS degree in engineering or technical field required.
• Minimum 5 years of relevant experience.
• Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
• Project management: ability to influence cross functional global teams spanning Quality, Operations, R&D, and Sourcing.
• Experience in process validation, design controls, risk management, CAPA, SCAR.
• Domestic and international travel up to 25%.

Responsibilities

• Lead new product development activities for SFMD onboarding of suppliers and products into Boston Scientific Quality System.
• Manage supplier qualification and ongoing performance monitoring.
• Plan and lead supplier audits; review observations; implement follow-up actions.
• Investigate and resolve non-conformances; drive corrective actions; document effectiveness.
• Support supplier change impact assessments and design changes within quality system.
• Champion quality system compliance and internal/external audits.

Skills

Project Management

Auditing & Compliance

Quality Systems

Regulatory Knowledge

Problem Solving

Cross-functional Collaboration

Supplier Quality

Education

BS degree in engineering or technical field

3+ years medical device engineering experience

Tools

Lead auditor ISO 13485

Job description

Boston Scientific is seeking a Supplier Quality Engineer III for Electrophysiology External Operations. You will support SFMD products, onboard suppliers, and lead quality deliverables across global teams. The role emphasizes patient safety, with a hybrid office schedule and travel up to 25%.

The position focuses on ensuring finished device quality, applying quality tools, and maintaining rigorous supplier qualification within the EP portfolio.